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Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00110370
First received: May 6, 2005
Last updated: November 26, 2007
Last verified: November 2007
History of Changes

May 6, 2005
November 26, 2007
April 2004
Not Provided
  • To test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior
  • in overall glycemic control (lower A1CF) at endpoint compared to to Glargine Basal-Bolus Therapy in combination
  • with OADs in patients with type 2 diabetes who have clearly failed to achieve glycemic goal
  • (A1C less than 7%) with once-daily insulin glargine in combination with OADs.
Not Provided
Complete list of historical versions of study NCT00110370 on ClinicalTrials.gov Archive Site
  • To test in both arms the following: frequency and incidence
  • of self-reported hypoglycemia, blood glucose data, 8-point profiles, insulin dose,
  • body weight, SAE's and study drug related AEs.
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Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes
A Comparison of Prandial Insulin Lispro Mixtures Therapy to Glargine Basal-Bolus Therapy With Insulin Lispro on the Overall Glycemic Control of Patients With Type 2 Diabetes Previously Treated With Oral Agents Combined With Insulin Glargine

The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Lispro Mixture Therapy
  • Drug: Glargine Basal-Bolus Therapy
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Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care. 2008 Jan;31(1):20-5. Epub 2007 Oct 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
April 2006
Not Provided

Inclusion Criteria:

  • Must have type 2 diabetes.
  • Must be 30-75 years of age at the time of Visit 1.
  • Must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
  • Must be on at least 30 units of glargine per day at enrollment.
  • Have an A1C between 7.5% and 12.0% at Visit 1.

Exclusion Criteria:

  • Must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
  • Must not have more than one episode of severe hypoglycemia in the last 6 months.
  • Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
  • Must not have congestive heart failure that requires medications.
  • Must not have had a kidney transplant or currently receiving dialysis
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00110370
9057, F3Z-US-IOOQ
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Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP